FDA.reportPublic FDA data

Application 040713

Type
ANDA
Sponsor
KVK TECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 5 · 95 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROMETHEGANPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe972025-10-20Boxed warning, Adverse reactionsName fallback
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7d766cf7-a21c-4eaf-bbdc-00f2939ef19a2025-10-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMajor Pharmaceuticals4cee8622-7d59-4794-8e32-54f7aac1d9232025-09-22Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBluePoint Laboratories44cd6d46-fbb9-4836-9426-d8ce2cb6d66d2025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma7a186bcd-ab8c-4695-8289-4cd33bb551cf2025-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.13d9e59d-eadb-41d5-9f47-9c11a6efb31c2025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d545105f-27dc-4820-b0b1-fcf17e0be0f02025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6f7e47cc-f823-4336-8107-f980e30496172025-06-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.1b1cee64-c0b5-4da6-92d0-1769350a51812025-06-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXttrium Laboratories, Inc.302bfea2-d403-d315-e063-6294a90a37dd2025-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEKesin Pharma Corporation28793bd2-bd40-4571-e063-6394a90ae7892025-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROMETHAZINE HYDROCHLORIDE
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.74834e1b-0d90-0542-e053-2991aa0aa1ef2025-02-10Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC2d996287-9eed-265a-e063-6294a90a69692025-02-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.12400c65-f93b-47a5-8167-1fb14337130b2025-01-07Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4c23037-e415-7604-e053-2995a90a5bb62024-12-31Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Lifesciences Limited4eaa8291-9cde-4205-857b-925ea8d618ba2024-12-04Name fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLC05907a49-537f-4bf2-8a5f-5e905f19fece2024-10-30Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions6aa6bfcc-024b-4ee2-a586-6c4ca879cea42024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions69eea039-0098-4e2f-a832-152583b16f052024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb7137912-d119-4899-9c93-09c1c625f2902024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Promethazine Hydrochloride
generic name: PROMETHAZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60429-151PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEGolden State Medical Supply, Inc.ANDACurrent